FDA 510(k)

Edwards eSheath Optima introducer set

K-번호: K252364 · 2025-08-29

결정일2025-08-29

제품 코드DYB

자문 위원회CV

결정Substantially Equivalent

기기 요약

Edwards eSheath Optima introducer set is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences. It received FDA 510(k) clearance on 2025-08-29 under 510(k) number K252364. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Edwards eSheath Optima introducer set?

Edwards eSheath Optima introducer set is a medical device that received FDA 510(k) clearance on 2025-08-29. The listed applicant is Edwards Lifesciences. The 510(k) number is K252364.

When did Edwards eSheath Optima introducer set receive FDA 510(k) clearance?

Edwards eSheath Optima introducer set received FDA 510(k) clearance on 2025-08-29, under 510(k) number K252364.

Who is the listed applicant for Edwards eSheath Optima introducer set?

The FDA 510(k) record lists Edwards Lifesciences as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Edwards eSheath Optima introducer set?

The FDA product code for Edwards eSheath Optima introducer set is DYB.

Edwards Lifesciences를 신청인으로 등재한 기타 기록

K254232ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150)K260105Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts K254279Edwards eSheath+ introducer set K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)K253034HemoSphere Stream Module K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2)

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